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Waterjet vs. scalpel: new trial tests gentler prostate cancer treatment

NCT ID NCT06651632

Disease control Sponsor: PROCEPT BioRobotics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new, less invasive treatment called Aquablation, which uses a high-speed waterjet to remove prostate tissue, to standard surgery (radical prostatectomy) for men with localized prostate cancer. About 280 men will be randomly assigned to one of the two treatments and followed for up to 10 years. The main goals are to see which approach better preserves urinary control and erectile function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aquablation Therapy (waterjet device)
What this could lead to
If successful, Aquablation could offer a less invasive option for treating localized prostate cancer with fewer side effects on urinary control and sexual function compared to full prostate removal.
What could go wrong
This is an early-stage comparison study, and it is not yet known if Aquablation controls cancer as effectively as surgery over the long term. There may be risks of incomplete cancer removal or recurrence.
Why investors are watching

Procept BioRobotics is running a randomized trial comparing its Aquablation Therapy to radical prostatectomy in 280 men with localized prostate cancer, with follow-up over 10 years. For a small company, this readout matters because it tests whether Aquablation can match or beat surgery on disease control, which would broaden its use beyond current settings.

If it works: A positive result could show Aquablation controls cancer as well as prostatectomy with fewer side effects, which may help the company expand its market and strengthen its position with doctors and patients.

If it fails: If the trial shows Aquablation is less effective at controlling cancer, or if it is delayed or fails, the company could face reputational damage and slower adoption. Trials often fail, so investors should expect uncertainty.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jan 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Biological male with age ≥ 45 years at the time of consent 2. Biopsy positive Grade Group 1-3 prostate cancer 3. Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment. 4. Clinical Stage ≤ T2c 5. PSA ≤ 20 ng/ml 6. Prostate volume ≥25 ml Exclusion Criteria: 1. Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy. 2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment. 3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion. 4. Patient is unwilling to accept a blood transfusion if required. 5. Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as: 5a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease). 6\. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated. 7\. Patient currently participating in other studies unless approved by Sponsor in writing.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Localized prostate cancer

Contacts and locations

Locations

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114, United States

  • Advanced Research

    Delray Beach, Florida, 33484, United States

  • Advocate Aurora Research Institute

    Sheboygan, Wisconsin, 53081, United States

  • Arizona State Urological Institute

    Chandler, Arizona, 85224, United States

  • Boulder Medical Center

    Boulder, Colorado, 80304, United States

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0A9, Canada

  • Chinese University of Hong Kong

    Shatin, Hong Kong

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • East Valley Urology Center

    Mesa, Arizona, 85206, United States

  • Endeavor Health

    Glenview, Illinois, 60026, United States

  • Florida Urology Partners

    Tampa, Florida, 33606, United States

  • Georgia Urology

    Atlanta, Georgia, 30328, United States

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, Hamsphire, RG24 7A, United Kingdom

  • Hospital da Cruz Vermelha

    Lisbon, 1549-008, Portugal

  • Integrated Medical Professionals, PLLC

    New York, New York, 10016, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kansas City Urology Care

    North Kansas City, Missouri, 64116, United States

  • Kearney Urology Center

    Kearney, Nebraska, 68847, United States

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Mountain View Hospital

    Idaho Falls, Idaho, 83401, United States

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Norfolk & Norwich University Hospital

    Colney, Norwich, NR4 7UY, United Kingdom

  • Potomac Urology

    Alexandria, Virginia, 22311, United States

  • Royal Free Hospital

    London, United Kingdom

  • The Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Tidelands Health Urology

    Murrells Inlet, South Carolina, 29576, United States

  • Trophy Point Urology

    Tampa, Florida, 33607, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Southern California

    Los Angeles, California, 90089, United States

  • University of Toronto

    Toronto, Ontario, M5S3H2, Canada

  • Universitätsklinikum OWL der Universität Bielefeld

    Bielefeld, Germany

  • Urology Austin

    Austin, Texas, 78745, United States

  • Urology Clinics of North Texas

    Dallas, Texas, 75231, United States

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